둘 다 구속력은 없음. but 참고 가능.
1. Source: GCP Questions, FDA Answers 2019 Edition
Subject Rescreening
Question:
Is rescreening of trial subjects who previously screen failed allowed? I am involved in a trial
where some trial subjects screen failed based on the original protocol. There has been an amendment
to the protocol which may make eligible the previously screen failed subjects now eligible to enter the
trial. Can these subjects who previously screen failed be rescreened?
Answer:
The question regarding “re-screening” that you have posed is influenced by specifics of the protocol,
the conditions which are being ruled in/out, etc. Therefore, this response needs to be understood
as a qualified response that is subject to modification based upon the facts of the case at hand, i.e.,
“the devil is in the details.”
Quite often protocols do not address screening of potential subjects and even more often do not address
re-screening of potential subjects. Depending on many diverse factors including the conditions that
are being evaluated, the tests that are being used for this evaluation, the reasons why initial screening
failed and the nature of the study, re-screening may or may not be medically/scientifically appropriate.
It is conceivable, however, that re-screening may make good sense if, for example, the reason
for original exclusion from the trial was based upon a self-limited predictably resolving condition or
based upon a laboratory test with a high false positive rate that, upon appropriate follow-up, proved to
be in error.
This is a question to put to the institutional review board (IR B) that reviewed the study and approved
it.
The IRB should have approved any and all consents used during the study, including those used
for the subject screening process.
2. MHRA forum thread
https://forums.mhra.gov.uk/showthread.php?1053-%91Re-consenting%92-trial-participants
‘Re-consenting’ trial participants
forums.mhra.gov.uk
Concerning re-screening, the approved protocol should state the criteria for re-screening, considering safety/ethical implications as well as any impact to the data integrity and statistical analysis. Many measures cannot just be repeated without adversely effecting the outcomes data. Often there may be a need to use alternative forms of certain scales and there may need to be a defined waiting period between screening and re-screening. In other circumstances re-screening may not be allowed at all. The approved protocol should give clear guidance about the procedure for re-screening, including tests that need to be repeated, if the subject needs to be considered a screen failure to be re-screened and any timelines that need to be considered. Data management procedures should also be defined in the appropriate site instruction materials according to approved practices.
In regards to re-consenting, ICDs must be signed prior to any study activities being conducted . Informed consent should be viewed as a process, rather than a single event;. Informed consent as a process includes maintaining the subject's consent during the entire study The site staff should also be aware that once the ICD is signed any observed or reported SAE must be reported …”
We are obliged by ICH GCP 4.8.2, to inform ongoing subjects in a timely manner, if new information becomes available that may be relevant and might impact their wish to remain in the study. Changes in the number or nature of visits would definitely impact the subjects willingness to continue in the trial ad therefore the subject should agree to this through a consent form.